Comparison of the Efficacy of Corticosteroid Injection and ESWT in Patients With CTS

Ahi Evran University Education and Research Hospital

Status and phase: Completed; Phase 4

Conditions: Carpal Tunnel Syndrome; Tenosynovitis

Treatments: Drug: local injection; Device: extracorporeal shock wave therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03792945

AhiEvranUERH

Details and patient eligibility

About

In this study, the investigators aimed to demonstrate the efficacy of ESWT (extracorporeal shock wave therapy) and local corticosteroid injection in patients with carpal tunnel syndrome(CTS) compared to participants receiving only splint and exercise therapy. And the investigators wanted to show that ESWT, a noninvasive treatment modality, is as effective and reliable as local corticosteroid injection, which is the least invasive treatment. Mild and moderate CTS patients will be determined according to American Association of Electrodiagnostic Medicine (AAEM) criteria. 90 idiopathic moderate and mild CTS patients will be included in the study. The participants will be informed about their participation in a study and written informed consent will be obtained.The demographic characteristics and disease duration of the participants will be recorded.The participants will be randomly divided into 3 groups.40 mg of local methylprednisolone (depomedrol) injection will be applied to Group 1 once.

And group 1 will also be given a hand wrist rest splint to use for 3 months, especially at night, when not using the hand. ESWT will be applied to Group 2 once a week for a total of 3 weeks and hand wrist rest splints will be given for 3 months especially at night when it is not in use. Group 3 (control group) will be given a hand wrist rest splint to use for 3 months, especially at night, when not using the hand. The evaluations will be repeated before treatment, after the first week after treatment (first ESWT application) and at the 3rd month. Hand grip strength measurement will be performed using Boston carpal tunnel syndrome questionnaire, visual analog scale and dynamometer.

Electromyogram (EMG) data will be recorded before and 3 months after treatment. During the trial, the routine will not be excluded.

Full description

In this study, the investigators aimed to demonstrate the efficacy of ESWT (extracorporeal shock wave therapy) and local corticosteroid injection compared to participants receiving only splint and exercise therapy. And the investigators wanted to show that ESWT, a noninvasive treatment modality, is as effective and reliable as local corticosteroid injection, which is the least invasive treatment. Mild and moderate CTS patients will be determined according to American Association of Electrodiagnostic Medicine (AAEM) criteria. Cervical radiculopathy, polyneuropathy, brachial plexopathy, systemic corticosteroid treatment, fracture and trauma history of the treated side anterior arm and wrist, inflammatory rheumatic disease, pregnant and lactating participants, participants with cardiac pacemakers, participants undergoing carpal tunnel syndrome surgery, thoracic outlet syndrome, severe atrophy, severe carpal tunnel syndrome, participants who are unwilling or unable to participate for any reason, and those who have been decided by the clinician that the participants is not in favor of the participants, systemic diseases such as renal failure, peptic ulcer, dm, hypothyroidism, coagulation disorder will be excluded.90 idiopathic moderate and mild CTS participants will be included in the study. The participants will be informed about their participation in a study and written informed consent will be obtained.The demographic characteristics and disease duration of the participants will be recorded. The participants will be randomly divided into 3 groups.40 mg of local methylprednisolone (depomedrol) injection will be applied to Group 1 once.

And group 1 will also be given a hand wrist rest splint to use for 3 months, especially at night, when not using the hand. ESWT will be applied to Group 2 once a week for a total of 3 weeks and hand wrist rest splints will be given for 3 months especially at night when it is not in use. Group 3 (control group) will be given a hand wrist rest splint to use for 3 months, especially at night, when not using the hand. The evaluations will be repeated before treatment, after the first week after treatment (first ESWT application) and at the 3rd month. Hand grip strength measurement will be performed using Boston carpal tunnel syndrome questionnaire, visual analog scale and dynamometer. Electromyogram (EMG) data will be recorded before and 3 months after treatment. During the trial, the routine will not be excluded.

Enrollment: 72 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women and male patients with carpal tunnel syndrome, tendinitis, tenosynovitis diagnosed between 18-65 years of age with clinical and EMG.
2. Patients who are able to understand and correctly understand the patient information form
3. Patients consenting to participate in the study according to the informed consent form

Exclusion criteria

1. Cervical radiculopathy
2. Polyneuropathy
3. Brachial plexopathy
4. Systemic corticosteroid treatment
5. Fracture and trauma history of the treated side anterior arm and wrist
6. Inflammatory rheumatic disease
7. Pregnant and lactating patients
8. Patients with cardiac pacemakers
9. Patients undergoing carpal tunnel syndrome surgery
10. Thoracic outlet syndrome
11. Severe atrophy
12. Severe carpal tunnel syndrome
13. Patients who are unwilling or unable to participate for any reason, and those who have been decided by the clinician that the patient is not in favor of the patient,
14. Systemic diseases such as renal failure, peptic ulcer, dm, hypothyroidism, coagulation disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 3 patient groups

extracorporeal shock wave therapy

Active Comparator group

Description:

ESWT will be applied to Group 1 once a week for a total of 3 weeks. Modus ESWT device will be used. The patient's wrist will be applied at a pressure of 4 bar and 2000 Hz at a frequency of 5 Hz. Patients will be given a carpal tunnel wrist brace at night and when they do not use their hands during the day. Participants will use the carpal tunnel wrist brace 3 months.

Treatment:

Device: extracorporeal shock wave therapy

local injection

Active Comparator group

Description:

40 mg of local Depomedrol (methylprednisolone) injection will be applied to group 2 once. Injection will be made from wrist with carpal tunnel syndrome.Patients will be given a splint at night and when they do not use their hands during the day. Participants will use the carpal tunnel wrist brace 3 months.

Treatment:

Drug: local injection

carpal tunnel wrist brace

No Intervention group

Description:

Patients will be given a carpal tunnel wrist brace at night and when they do not use their hands during the day. Participants will use the carpal tunnel wrist brace 3 months.